Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022792

FEI Number

3003886275

Entity Name

GREATLAND ENTERPRISE CO., LTD.

City/State/Country

Lukang Changhua, TW

Establishment Address

276 Chang-Lu Road, Sec. 5, Lukang Changhua 505, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

GREATLAND ENTERPRISE CO., LTD. (Owner Number: 8022792)

Owner / Operator Contact Address

276 Chang-Lu Road, SEC. 5, Lukang, TW-CHA 505, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nines Renegade Safetyvu 7eye Nines Renegade

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	1987-02-12
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2011-10-21
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	1981-05-29
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2017-08-10
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	1987-02-12

Official Correspondent

Jocelyn Chen

US Agent Details

Harry Lei Business: Eye Ojo Corp. Email: harrylei@eyeojo.com Phone: (909) 9230899

Related Public Records

Same Entity

GREATLAND ENTERPRISE CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

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3042870833	GOLEADER(VIETNAM) RECREATION LIMITED	Tan Phuoc 3 Commune Dong Thap, VN
3009141079	STAGE	Sandy, UT, US
3013857947	FARFETCH ITALIA S.R.L.	MILAN Milano, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022792. Last updated year: 2026. Please use registration number 8022792 when referencing this establishment in official correspondence.